EMA CHMP meeting: 12 medicines recommended, withdrawals and re-examinations

Positive opinions

The CHMP recommended 12 medicines for marketing authorisation. Notable positive opinions included Frehemgo (denecimig) for prophylaxis of bleeding in haemophilia A; Gevalka (ensartinib) for ALK‑positive advanced non‑small cell lung cancer; Klygefa (gefurulimab) for generalised myasthenia gravis; Lifyorli (relacorilant) for platinum‑resistant epithelial ovarian, fallopian tube or primary peritoneal cancer; and Povofortay (povorcitinib) for active moderate to severe hidradenitis suppurativa, described as the first oral daily option for adults refractory or intolerant to anti‑TNF therapy.

Other recommended medicines include Sepalna (senaparib) as maintenance therapy for advanced epithelial high‑grade ovarian, fallopian tube or primary peritoneal cancer; VaxRabeo (inactivated rabies vaccine) for pre‑ and post‑exposure prophylaxis in all age groups; and Zeydovio (glepaglutide) for short bowel syndrome. The committee also adopted positive opinions for two biosimilars, Adcomfo (omalizumab) and Pebrilzo (pertuzumab, the first biosimilar recommended following the tailored clinical approach), and two generics, Inijaq (tofacitinib) and Ruxolitinib Zentiva (ruxolitinib).

Extensions of indication

The CHMP recommended a change to Anzupgo to lower the age of administration to adolescents 12 years and older for chronic hand eczema. It also recommended extensions of indication for ten authorised medicines: Abiraterone Mylan, Cosentyx, Enhertu, Jyseleca, Keytruda, Ocrevus, Padcev, Pepaxti, Sogroya and Tecvayli.

Withdrawals and re-examinations

Two initial marketing‑authorisation applications were withdrawn: Isembyld (apitegromab) for 5q spinal muscular atrophy and Zinmyleo (trilaciclib) to reduce chemotherapy‑induced myelosuppression in extensive‑stage small‑cell lung cancer. Three indication‑extension applications were also withdrawn: Alhemo (concizumab) for children under 12, and Kaftrio and Kalydeco for use in children aged one year and older in specified combinations. Question‑and‑answer documents on these withdrawals are available.

Applicants for Kemsu (sufentanil/ketamine), Meplyffa (arimoclomol) and Qezzaqar (catequentinib) have requested re‑examination of negative CHMP opinions issued in July 2026; the CHMP will re‑examine on receipt of the grounds. Following re‑examination, the committee confirmed its recommendation to refuse marketing authorisation for Xervyteg (allogeneic faecal microbiota, pooled) for treatment of acute graft‑versus‑host disease.

Referrals, agenda and statistics

The CHMP finalised its review of medicines containing ipidacrine and recommended restricting and better defining approved uses to align with available data and standard of care. The committee also concluded that the benefits of sodium oxybate (175 mg/ml) syrup and oral solution continue to outweigh risks for acute alcohol withdrawal syndrome and long‑term abstinence support, while additional studies are required to further characterise efficacy. The meeting agenda is published on the Agency website and minutes will follow; CHMP statistics for the meeting are provided in the published graphic.